| Trial ID # | NCT03748186 |
| Phase | I |
| Drug Class | Antibody Drug Conjugates: FRalpha |
| Drug Name | Luveltamab tazevibulin |
| Alternate Drug Names | STRO-002, anti-folate receptor-alpha antibody drug conjugate STRO-002 |
| Drugs in Trial | Luveltamab tazevibulin |
| Eligible Participant | Platinum resistant or refractory ovarian cancer |
| Patients Enrolled | 31 patients in dose escalation; 44 patients in dose expansion, median 3 prior therapies (1-3) |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | CBR, ORR, DCR, DoR, PFS, evaluated per RECIST |
| Efficacy | Results from dose escalation, doses 2.9 mg/kg and above: ORR: 32% (1CR, 4PR, 5uPR, n=31) Results from expansion at 4.3 mg/kg and 5.2 mg/kg: Exploratory analysis, FRalpha expression by TPS %, dosing 4.3 mg/kg or 5.2 mg/kg: |
| Clinically Significant Adverse Events | Serious AE: febrile neutropenia (n=1) |
| Conclusion | Luveltamab tazevibulin (STRO-002) is well tolerated with evidence of anti-tumor activity in heavily pretreated patients across a broad range of FRα expression levels. No ocular toxicity signals have been observed. |
| Reference | Naumann RW et al. Phase 1 dose-escalation study of STRO-002, an antifolate receptor alpha (FRα) antibody drug conjugate (ADC), in patients with advanced, progressive platinum-resistant/refractory epithelial ovarian cancer (EOC). J Clin Oncol (2021) 39 (suppl 15; abstr 5550) Naumann RW et al. Poster Oaknin A et al. Luveltamab tazevibulin (STRO-002), an anti-folate receptor alpha (FolRα) antibody drug conjugate (ADC), safety and efficacy in a broad distribution of FolRα expression in patients with recurrent epithelial ovarian cancer (OC): Update of STRO-002-GM1 phase 1 dose expansion cohort. J Clin Oncol 41, 2023 (suppl 16; abstr 5508) Oaknin A et al. Slide from presentation |